Development and Validation of RP-HPLC and UV Spectroscopic Method For Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Linagliptin in Synthetic Mixture

Abstract

A simple, rapid and selective UV Spectroscopic (Absorbance Correction Method) and RP-HPLC methods were developed and validated in accordance with ICH Q2(R1) guidelines for the simultaneous determination of Dapagliflozin Propanediol Monohydrate and Linagliptin in the synthetic mixture. Methanol has been used as a solvent in the development of UV Spectroscopic Methods for Dapagliflozin Propanediol Monohydrate and Linagliptin respectively at 238nm and 296nm. RPHPLC method has been developed using a mobile phase containing mixture of 0.01M Potassium dihydrogen orthophosphate (KH2PO4) Buffer (pH 3.0): Acetonitrile (60:40) with the flow rate of 0.8 ml/min at 35ᵒC column oven temperature. An Agilent Eclips C18 column (150mm x 4.6mm x 5μm) was used as a stationary phase and detected at 230nm. The retention time of Dapagliflozin Propanediol Monohydrate and Linagliptin were 5.039min. and 2.293min. respectively. Linearity was observed in the concentration ranges of 10-60μg/ml for DAPA and 5- 30μg/ml for LINA using absorbance correction method and 6-36μg/ml for DAPA and 3-18μg/ml for LINA using RP-HPLC method with correlation coefficient of 0.999. The percentage recoveries obtained for DAPA and LINA were 98.96-99.64% for UV Spectroscopic and 99.83-101.71% for RP-HPLC techniques. The %RSD value for precision of Dapagliflozin Propanediol Monohydrate and Linagliptin were within acceptable range in both methods. For the simultaneous estimation of Dapagliflozin Propanediol Monohydrate and Linagliptin, which was employed for quantitative analysis, the established approach is precise, accurate, specific, easy to use, and economical.